Blood flow problems within the thoracic cavity, especially when in relation to the heart, are serious medical concerns. Coronary thromboses (heart attack) in particular is ultimately the leading cause of death for men and women in the developed world, and angina pectoris (chest discomfort relating to coronary artery narrowings) afflicts about 16 to 20 million citizens in the United States alone.
Emergency treatment of Acute ST Elevation Myocardial Infarction (STEMI), the most feared and serious form of heart attack, is commonly by Primary Percutaneous Coronary Intervention (PPCI—otherwise termed angioplasty, where a balloon and typically a stent is inserted within a thrombosed coronary artery to restore flow), or if a patient cannot reach a cardiac cath-lab where PPCI is performed within 90 minutes, they may receive intravenous thrombolytic drug therapy which alternatively dissolves the coronary thrombosis.
There are always delays to treatment in execution of PPCI, and sometimes because of distal embolization, poor or no reflow following the PPCI procedure take place which leads to poor patient outcomes. Thrombolytic drug therapy while offering early revascularization (which is highly desirable, as “time is muscle”) unfortunately does not have a high success rate with only about 50% of cases achieving an acceptable level of reperfusion (restoration of blood flow) within 90 minutes of administration of therapy, hence adjuncts to these technologies to promote early reperfusion are required.
Recently non-invasively delivered, Localized, Low Frequency Vibration (LLFV) administered upon the thoracic cavity in the sonic to infrasonic ranges (i.e. between 1-1000 Hz, 0.1-10 mm, preferably 20-120 Hz, 1 mm-10 mm, optimally about 50 Hz, greater than 2 mm), such as applied to rib-spaces of the anterior chest wall (or more specifically to the anatomic left and right of the sternum at the level of the fourth intercostal space), has received attention as a possible adjunct to clot dissolving drug therapy in the emergency treatment of STEMI.
Chest wall administered LLFV causes clot disruption and disadhearment of coronary thrombosis from a blocked endothelial surface of an ulcerated plaque (the most common etiology of STEMI), vasodilation of a culprit coronary artery (which is often in a state of spasm), and improves mixing of systemically delivered clot dissolving agents, through introduction of convection currents, down a zero flow thrombosed coronary circulation.
LLFV when applied exclusively in the diastolic period of the cardiac cycle (hereinafter “Diastolic LLFV”), particularly improves coronary flow. Diastolic LLFV relaxes the myocardium (and thereby decreases intra-myocardial vascular tone) and lowers the left ventricular diastolic pressures, which further promotes coronary flow from epicardium to endocardium. Diastolic LLFV is also useful to prevent “no flow” or “low flow” reperfusion which may occur following PPCI or IV thrombolysis—whereby the distal clotted fragments embolize and occlude the more distal circulatory beds within the myocardium.
Diastolic LLFV advantageously confers a positive contractile effect to the heart in treatment of heart failure or cardiogenic shock, as besides improving myocardial perfusion, also improves relaxation of the left ventricle which improves diastolic filling and thereby increases stroke volume by Starlings Law. Diastolic LLFV thereby comprises a preferred treatment for STEMI, such as to prevent or treat complications of associated heart failure or cardiogenic shock, which not uncommonly accompany STEMI, and which generally otherwise carry a poor prognosis. Diastolic LLFV can also be used more generally in an intensive care unit for any condition which requires a temporary ventricular assist, such as in cases of heart failure or cardiogenic shock as an adjunct to medical therapy or a bridge to more invasive cardiac assist measures.
In chronic out patient therapy, the delivery of chest wall LLFV also causes sheer stresses to the coronary endothelium which are know to induce the vessels to undergo angiogenesis, or more broadly growth of coronary arterial vessels. Diastolic LLFV, because of its positive effect on ventricular performance and assisting coronary blood flow, may be preferable and safer for such patients, who often have a cardiomyopathy with reduced ejection fraction concomitant with their coronary arterial disease. Chest wall LLFV thereby also offers a valid long term treatment option for angina pectoris.
LLFV applied with randomized frequency changes (hereinafter “Randomic LLFV”), which adds turbulence to a treated coronary artery, is a preferred vibratory waveform for disrupting thrombosis (such as in treatment of STEMI) and stimulating the coronary endothelium for up regulating angiogenic beneficial mediators to cause angiogenesis.
It has been ascertained by the Applicant, that to ensure optimized chest wall LLFV penetration to the heart (and coronary arteries thereupon), there is a need to, besides vibrating across the sternum at the fourth intercostal space (which advantageously matches the anatomic configuration of the left and right coronary artery), also vibrate simultaneously the anatomic left third intercostal space generally proximate the left sternal margin, as the left third intercostal space is anatomically situated in most cases directly over the base of the heart whereby the left coronary system arises.
The left fourth intercostal space comprises a particularly reliable acoustic transmission window from the chest wall to the heart as the acoustic transmission pathway is not typically interfered by from lung (which contains air and thereby does not transmit acoustic energy). The acoustic penetration pathway between the anatomic left third intercostal space proximate the sternal margin and the heart however, while most often ideally situated over the base of the heart, is often blocked by lung (up to about 50% of the time), and hence is somewhat unreliable. It is thereby advantageous to, besides vibrating across the sternum across the fourth intercostal space, also simultaneously vibrate the anatomic left third intercostal space, to ensure optimized transmission of vibration from the chest wall to the coronary arteries of the heart.
Jap. Pat. No. JP 8,089,549 (“549”) to Koiwa and Honda discloses a noninvasive 50 Hz Diastolic LLFV system via a singular mechanical probe to skin coupling interface which enhances myocardial perfusion in view to treating heart failure. The '549 patent increases coronary blood flow to stable patients with known coronary artery narrowings, through a prescribed method of applying vibration specifically timed to the diastolic phase of the cardiac cycle. The disclosed single probe to skin coupling however, as eluded to above, is a sub-optimal means of vibration to chest wall transmission and penetration as only one rib-space over the heart must be chosen.
Low frequency vibrators with a pair or greater than a pair of contact nodes are well known for therapeutic massage of sore tired muscles and in chest wall applications for mobilization of pulmonary congestions, but have generally found no utility in the treatment of acute or chronic vascular obstructions in treatment of coronary artery disease or other related blood flow afflictions which may particularly occur within the thoracic cavity.
Common commercially available devices with a plurality of contact nodes which enable multiple rib-space contact such as to the anatomic left and right of the sternum (e.g. Mini Pro 2 Thumper, Thumper, Homedics Professional Percussion Massager, Sharper Image HF575 Percussion Massager, Brookestone Therepsa Percussion Massager), while potentially useful for administration of chest wall LLFV in treatment of cardiac ailments, are not ideal as the devices do not have a third contact node enabling simultaneous contact to the left third intercostal space. Furthermore, for those massagers which offer adjustable contact node spacing, the contact nodes cannot be disposed close enough relative to one another to enable simultaneous percussion to the anatomic left third and left fourth intercostal space at or near the left sternal margin of a human adult subject. Also, even if the contact nodes on these devices could be brought closer together, the adjustable spacing features for these types of devices are performed by manual controls (either electronic or mechanical) which would require pre-measuring a distance between the rib-spaces of a patient, and then attempting to manually adjust the contacts—which at best comprises an awkward, time consuming, and somewhat inaccurate step.
It would thereby be desirable from a ease of application stand point to provide a vibratory attachment interface for a vibration massager, which besides providing a pair of contact nodes which can simultaneously seat to the anatomic left and right of the sternum (such as at the fourth intercostal space), would also provide at least a third contact node which would, once forcefully applied generally over and upon the left third intercostal space, automatically gravitate to an optimized, flush, opposed seating within such left third intercostal space, without the need of an awkward, operator controlled manual measurement and application step.
In reference to FIG. 1, co-pending U.S. patent application Ser. No. 12/154,508 filed by the present applicant (of which the present application is a continuation in part) discloses a vibratory attachment interface 100 with adjustably spaced contact nodes which are advantageously enabled to simultaneously seat across a patient's sternum, and within the anatomic left third and left fourth intercostal space. The attachment interface 100 disclosed comprises manually spaced contact nodes 12 with screws 26 and support arms 22 whereby contact nodes 12 are slideably mounted upon an elongated member 24. Elongated member 24 is attachable to a vibratory post 16 of a vibration massager (massager not shown) which oscillates up and down to cause vibration. Technically, if screws 26 were left loose during engagement of the attachment interface to a chest wall surface, positioning of a first contact node 12a upon a first rib-space (such as the left fourth intercostal space) could foresee ably derive by engagement force and natural contour migration an automatic movement of a second contact node 12b to gravitate and optimally seat or nestle within a second intercostal space (such as the left third intercostal space) without need of a particular manual positioning step. However, this was not how the attachment interface 100 was intended nor designed for use, and the migration of contact nodes 12a and 12b would not necessarily function in this particular manner depending on the initial (pre-engagement) position of the second contact node relative to the first.
As can be seen from above, there is a need for an improvement to the U.S. Ser. No. 12/154,508 attachment interface 100, so that when a first anatomically leftward situated contact is seated within a fourth intercostal space, a directly opposing anatomically leftward contact would automatically gravitate to its optimal fitted (or substantially flush or opposed) position within the third intercostal space (or vise versa), without the need of pre-measuring or manual adjustments and re-configurations by an operator.